Identity
- Trade Name
- Research and Diagnostic Systems FDA UDI
- Generic Name
- Full blood count IVD, calibrator FDA UDI
- Device Name
- CD-Cal (Calibrator): 2 x 3mL FDA UDI
- Model / Reference
- 3KC11 FDA UDI
- Description
- CD-Cal (Calibrator): 2 x 3mL FDA UDI
Identifiers
- Catalog Number
- 3KC11 FDA UDI
- Primary DI / UDI-DI
- 10815762020930 FDA UDI
- 510(k) Number
- K003991 FDA UDI
- FDA Product Code
- KRX FDA UDI
- GMDN Term
- Full blood count IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 6 Milliliter FDA UDI
Category: Full blood count IVD, calibrator
Research and Diagnostic Systems by Research And Diagnostic Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K003991 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Research And Diagnostic Systems, Inc.
Sources (1)
- FDA UDI 8edcf8cb-48db-4da1-9631-620c0d175bc5 38 fields · synced May 30, 2026